- LOGIN
- MemberShip
- 2026-04-16 22:48:39
- Opinion
- [Reporter’s View] Not penalty but incentive to generics
- by Lee, Tak-Sun Jun 09, 2020 06:26am
- Under the grandeur name of ‘strengthening market competitiveness,’ Korean-made generics are to face various changes in policy in the future. Concerned of excessive number of generics weakening the market competitiveness, the Korean government has already attempted to restrict joint bioequivalence test and reduce pricing of generics with cosigned bioequivalence test result. But it was scrapped by the Regulatory Reform Committee. However, Ministry of Food and Drug Safety (MFDS) is unceasingly reviewing a number of plans to better manage generics with public-private consultative body. So far, they have mentioned of specially labeling package of drugs that conducted individual bioequivalence test, setting bioequivalence quality assessment indicators, and building a database on generic products by each substance. Regardless, only the time will tell, if all these actions would effectively improve generic products’ competitiveness. Unfortunately, most of the competitive enhancement plans are focused on ‘penalty.’ The policy to bring down the pricing of generics without individual bioequivalence test result is a good example. The public-private consultative body was on the same page about being more selective with generics. Naturally, the products at the end of the line would feel penalized. Nothing is more inspiring than a compliment. And we would have to see if the Korean-made generics, tattered by restricting regulation, would survive in the market with so-called ‘strengthened competitiveness.’ Rather, these restraints may even advertise generic as a lower-quality version of the original. Therefore, a means to grant incentives to well-developed good-quality generics should be discussed as well. For instance, the government should consider policies to provide benefit on patent-evading generic with preferential sales approval, generic with an overseas export deal and products contributing to save NHI finance through lowered price. Only when the government promotes the good side of generics, the market would be confident enough to trust those generics. Hopefully, the government would seek for policies granting incentives, besides the penalties, to improve generics’ market competitiveness.
- Policy
- AZ-China joint venture Dizal tests drug in Korea
- by Lee, Tak-Sun Jun 08, 2020 06:15am
- Dizal Pharma, a joint venture company by AstraZeneca and a Chinese firm, is initiating a clinical trial in Korea on non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) or human epidermal growth receptor 2 (HER2) mutation. The pharmaceutical industry is paying a close attention on the Chinese company’s clinical trial, as Hanmi Pharmaceutical and Takeda are also developing a treatment targeting both patient groups either with EGFR mutation or HER2 mutation. On June 5, Korea’s Ministry of Food and Drug Safety (MFDS) has approved of the transnational phase 1/2 clinical trial protocol on 'DZD9008,' submitted by a global clinical CRO firm Covance Korea. The clinical trial aims to confirm the safety, tolerability, pharmacokinetics and antitumor activity of DZD9008 in advanced NSCLC patients with EGFR or HER2 mutation. DZD9008 is an investigational anticancer agent in development by a Chinese-based company, Dizal Pharma. The pharmaceutical company is a joint venture company by a global pharmaceutical company AstraZeneca and China Future Industry Investment Fund (FIIF). In April last year, China’s National Medical Products Administration (NMPA) approved a clinical protocol on DZD9008, and soon after the joint venture company submitted an Investigational New Drug Application. EGFR mutation is frequently expressed in NSCLC patients and HER2 mutation in breast cancer patients. Targeted therapies for respective cancer types have been developed. However, a drug to cover both patient groups with EGFR or HER2 mutation has not been approved to date. In Korea, clinical trials on Hanmi Pharmaceutical’s poziotinib (phase 2 trial on NSCLC patients with EGFR or HER2 exon 20 mutation) and Takeda’s mobocertinib (phase 1/2 trial testing EGFR/HER2 inhibitor in NSCLC patients) are in progress at the movement. The clinical trial on DZD9008 would call for 44 participants in Korea (180 participants worldwide) and conducted in Catholic University of Korea—St. Vincent’s Hospital, National Cancer Center, Seoul Samsung Medical Center, Seoul National University Hospital and Seoul Asan Medical Center. So far, none of Chinese-based pharmaceutical company has made it in Korean market, and even a finished product from China is rare to find. But a couple of Chinese pharmaceutical companies are reportedly conducting clinical trials in Korea.
- Company
- Customized Rx considering the patient's condition is needed
- by Eo, Yun-Ho Jun 08, 2020 06:13am
- The need for patient-specific prescriptions is emerging in the field of obesity treatment. At the recently held 'Saxenda e-Class' (Saxenda.livesympo.com), Professor Hye Jin Chun of the dept. of Family Medicine at Cha University Bundang Medical Center had a time to cover information about treatment for obesity. On this day, Professor Hye Jin Chun focused on six types of obesity treatments including Saxenda (Liraglutide), Xenical (Orlistat), Dietamin (Phentermine), Qsymia (Phentermine+ Topiramate), Belviq (Lorcaserin), Contrave (Naltrexone HCl/ Bupropion) that passed the approval standards of the MFDS. Of these, drugs that have been approved by the US FDA and European EMA are Saxenda, Xenical, and Contrave. She said, "In the case of appetite suppressants that act on the central nervous system, such as Phentermine or Phentermine/Topiramate combinations, anxiety or depression may worsen in patients taking psychiatric drugs, and attention to suicidal behavior is necessary. The prescription is contraindicated for patients who are mentally very anxious or excited." Saxenda was the preferred treatment option for these patients. Prof. Jeon said, "Saxenda is 97% similar to GLP-1, an appetite regulating substance in the human body that is naturally secreted in response to food intake, and is an obesity treatment that has confirmed efficacy and safety through long-term clinical data for 3 years." Saxenda's globally licensed clinical trials show that 63% of patients with an overweight loss of 5%, 33% of patients with weight loss of more than 10%, and 14% of patients with weight loss of more than 15%, 9 out of 10 Showed weight loss effect. In addition, it was the only obesity treatment to obtain indications in obese patients with pre-diabetes, and it proved the effect of improving various metabolic risk factors such as blood sugar, blood pressure, and blood lipid levels in addition to weight loss. Professor Jeon also introduced a case study of a patient who actually lost weight through Saxenda. The patient was a woman in her 50's and was overweight with a BMI of over 32kg/m2. At the time of the first treatment, she showed resistance to injection treatment, enjoyed a late night snack, and had a high craving for food, so Contrave was prescribed, but after 4 days of taking, she complained of severe headache and nausea, and changed the drug to Dietamin. After 2 weeks of treatment, the weight was slightly reduced, but the prescription drug was changed to Saxenda by complaining of insomnia, dry mouth and throbbing, which are typical characteristics of Phentermine. She also complained of stomach discomfort and proceeded to increase slowly than the basic increase schedule as she administered Saxenda and lost weight to 28.3kg/m2 BMI through Liraglutide combination with improved lifestyle. Professor Jeon said, “It is necessary to guide patients who visit hospitals for obesity treatment by identifying drugs that can be prescribed for a long period of time so that patients can be prescribed safe treatments. Safe and effective treatment must be achieved through the proper application of drugs based on the evidence."
- Policy
- The copayment of Remdesivir is supported by the government
- by Kim, Jung-Ju Jun 08, 2020 06:11am
- While the government announced that it would make special imports of Remdesivir, which is being evaluated as COVID-19 treatment, the quarantine authorities said that the cost of treatment is likely to be paid by the NHIS, and the patient's cost of liability is likely to be paid by the government. Eun-kyung Chung, the head of the Central Disease Control Headquarters, made a statement today (4th) regarding the special import of Remdesivir in the regular briefing Q&A. According to her, the current government has begun to negotiate a secured supply with Remdesivir for imports. In this process, the drug price will be decided, it has not been determined how much will be secured and how much it will cost. However, since this drug will be brought into Korea in the form of an orphan & essential Drug, the cost of this drug is likely to be borne by the health insurance finances and national finance. "This drug is an orphan & essential Drug, so the government will secure it and proceed with treatment in consideration of indications," said she. "Currently, COVID-19 is the first-class infectious disease. The charges are borne by NHIS and it is highly likely that the patient's co-payment will be enforced by the country." She said that detailed guidelines will be summarized and announced when plans to secure products such as drug prices and volumes become detailed in the future.
- Policy
- Court dismisses request to revoke Galvus IMD approval
- by Lee, Tak-Sun Jun 08, 2020 06:11am
- Novartis’ request to revoke Korea’s Ministry of Food and Drug Safety (MFDS) approving Hanmi Pharmaceutical’s Vildagle (vildagliptin hydrochloride) has reportedly been dismissed. In May, Novartis has filed a litigation to cancel a drug approval on Vildagle 50 mg tablet, claiming the Korean-made drug did not fulfill the duty to notify the patent owner when processing the item approval. On June 4, the industry reported Seoul Administrative Court has dismissed Novartis’ request to nullify the drug approval. Although the court did not disclose the reason behind the decision, the industry suspects the lack of precedent canceling the ministry’s approval has played a part. Novartis As a result, MFDS’ approval on Vildagle 50 mg tablet would be sustained. Hanmi Pharmaceutical’s Vildagle has been approved by MFDS on Jan. 21 as an incrementally modified version of Novartis’ DPP-4 antidiabetic drug Galvus tablet (vildagliptin). Hanmi Pharmaceutical received the approval except on the indication that Galvus extended the original’s substance patent for. The Korean company argues the drug has evaded the substance patent to be expired on Mar. 4, 2022. Currently, the Intellectual Property Trial and Appeal Board is reviewing the case. Novartis, on the other hand, states the approval on Vildagle was not fairly process, as Hanmi Pharmaceutical disregarded the duty to notify the patentee according to the drug approval-patent linkage system. However, Hanmi Pharmaceutical and MFDS refute the Korean company was not required to notify the multinational company as the item did not infringe the original’s patent. Regardless of the court dismissing the request, Novartis plans to continue addressing the dispute during the litigation. After receiving a pricing of 403 won per tablet in April, Hanmi Pharmaceutical is contemplating on the launch of Vildagle. And Novartis has already filed litigation on patent infringement and injunction against Vildagle before the launch.
- Company
- Celltrion, begins development of Insulin pen biosimilar
- by An, Kyung-Jin Jun 08, 2020 06:11am
- View of CelltrionCelltrion is working with a domestic medical device company to develop an insulin biosimilar. The goal is to secure cost competitiveness and lower dependence on imports by developing a pen-type insulin injection for the first time in Korea. Celltrion’s insulin pipeline was selected as a state-designated project by the Korea Evaluation Institute of Industrial Technology (KEIT). The four-year development will require a total budget of ₩4 billion, of which ₩3 billion will be supported by the government. The two companies focused on developing a pen-type injection that can be automatically administered up to 80 units once. The intention is to commercialize domestic insulin pen-type injections using domestic materials. Celltrion is in charge of insulin biosimilar development and clinical trials, and Poonglim Pharmatech plays a role in charge of developing an auto pre-filled pen type injector that can be used by filling in biopharmaceuticals developed by Celltrion. It will be commercialized by 2025 through four years of research and development. Currently, 96 percent of the global insulin market is taken by Sanofi, Eli Lilly and Novo Nordisk. Biosimilar products are also sold only by Sanofi and Lilly. In the domestic insulin market, there were many opinions that the localization of the product was urgent as Novonordisk occupied 45%. The national assignment project evaluation committee is also known to give a high score to reduce the dependence on imports if 'Korea's No. 1' product with quality and cost competitiveness is released in consideration of such market conditions. Half out of an estimated 463 million global diabetic patients use pen injectors, Celltrion said, adding that the market is annually growing by 9 percent. By 2023, the pen insulin market size is predicted to hit ₩37 trillion. An official from Celltrion said, “The selection of the target for this national project is the result of the recognition of the technological development innovation of both companies and the know-how and development of the market in the future.” "We expect diabetic patients around the world to benefit from more convenient treatments at lower cost."
- Policy
- Abbvie’s Rinvoq was approved
- by Lee, Tak-Sun Jun 05, 2020 06:10am
- Another oral rheumatoid arthritis drug has been approved in Korea. It is Abbvie’s Rinvoq sustained-release tablet 15mg (Upadacitinib). The competing drugs include Pfizer’s Xeljanz (Topacitinib), Lilly' Olumiant (Baricitinib), and Astellas' Smyraf (Peficitinib). On the 4th, the MFDS approved Abbvie’s Rinvoq 15mg as a new drug. It is used to treat moderate to severe active rheumatoid arthritis in adults who do not respond appropriately to one or more anti-rheumatic agents (DMARDs) or who are intolerant. It can also be administered alone or in combination with Methotrexate or other non-biological anti-rheumatic agents (DMARDs), but not with biological anti-rheumatic agents (DMARDs) or other Januskinase (JAK) inhibitors. It is a drug that is administered orally 15 mg once a day regardless of meals. It is more convenient to use than the TNF alpha-blocking injection that is commonly used in rheumatoid arthritis patients. In five cases of Phase III trial, Rinvoq proved effective in rheumatoid arthritis patients. In addition, the response rate was higher than that of the control drug such as MTX monotherapy or placebo group. In Korea, there are a lot of oral drugs of the JAK inhibitor series, such as Rinvoq, Pfizer's Xeljanz, Lilly's Olumiant, and Astellas' Smyraf. They have been approved in Korea and are on the market. Xeljanz recorded sales of ₩14.7 billion based on IQVIA last year, and is competing with TNF alpha blocker in the antirheumatic arthritis market. Olumiant recorded ₩2.2 billion in the market last year. Sales of oral JAK inhibitors are expected to increase significantly if Astellas' Smyraf which was approved in January and Abbvie’s Rinvoq are released in the domestic market.
- Company
- Unpredictable Cancer Committee make all kinds of decisions
- by Eo, Yun-Ho Jun 05, 2020 06:10am
- The expression on all the pharmaceutical companies accepting the final outcome varied as the meeting concluded. But for sure, no one had a perfect game. On June 3, Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee was convened to discuss two immunotherapies, two poly ADP-ribose polymerase (PARP) inhibiting targeted therapies and two multiple myeloma treatments. ◆ Keytruda and Opdivo The decision on MDS’s Keytruda (pembrolizumab) has been deferred yet again. The Committee reviewed granting reimbursement on Keytruda’s five indications, including first-line treatment (monotherapy and combination therapy) for non-small cell lung cancer (NSCLC), monotherapy for second or later-line treatment in bladder cancer, and monotherapy for third or later-line treatment in or refractory classical Hodgkin lymphoma. In the April meeting finally convened after being postponed twice due to COVID-19, the Cancer Committee deferred the decision on the immunotherapy. Although not required, the multinational company submitted an economic evaluation data and financial impact solution plan on using the immunotherapy as a first-line treatment (mono and combination therapy) in patients with non-small cell lung cancer (NSCLC) to better express its commitment to receive the extended reimbursement. Regardless, the committee did not give a satisfying answer, explaining that they did not have sufficient time to review properly. Bristol Myers Squibb (BMS) and Ono’s Opdivo (nivolumab), on the contrary, gave up on the lung cancer indication and won the benefit in Yervoy (ipilimumab) combination therapy. Apparently, BMS and Ono have also submitted an economic evaluation data to secure the coverage on Opdivo plus Yervoy combination therapy. In April, the Cancer Committee cleared the reimbursement on Opdivo for a second-line therapy for relapsed or metastatic head and neck squamous cell carcinoma (HNSCC) and a second-line therapy for classical Hodgkin lymphoma (CHL), but denied the indication on second-line renal cell carcinoma therapy and third-line stomach cancer therapy. And at the latest meeting, the committee gave a nod to Opdivo’s indication to treat renal cell carcinoma as a first-line therapy. After receiving the first reimbursement as a second-line therapy in patients with NSCLC in September 2017, Opdivo has taken three years to pass the Cancer Committee. ◆Lynparza and Zejula Without a surprise, the Cancer Committee’s answer to PARP inhibitor’s indication on BRCA-negative patients was ‘no.’ AstraZeneca’s Lynparza (olaparib) and Takeda Pharmaceutical’s Zejula (niraparib) were half-successful in the end. The Cancer Committee reviewed Lynparza’s tablet indicated to as a maintenance therapy following a first-line therapy in patients with BRCA-mutated advanced ovarian cancer, second or later-line treatment in platinum-sensitive patients with relapsed high grade serous epithelial ovarian, treatment in patients with HER2-negative metastatic breast cancer. The committee recognized the need for first and second-line maintenance therapy in BRCA-mutated ovarian cancer, but ruled out mBRCA-negative patients included in the second-line therapy indication. Also, the committee seemed skeptical of the breast cancer indication. Zejula also had a similar outcome. The review was on using the drug as maintenance therapy of patients with gBRCA-negative high-grade serous relapsed ovarian cancer who showed complete or partial response in platinum-based chemotherapy, and as monotherapy in patients with relapsed ovarian cancer who previously received fourth-line or later chemotherapy. Ultimately, only the fourth-line monotherapy indication was approved, while the gBRCA-negative indication failed. The government is still conservative about an anticancer treatment indicated to treat ‘all comers.’ ◆ Revlimid and Pomalyst Multiple myeloma treatments seem to be struggling with maintenance therapy. Deferred by the Cancer Committee last September, Revlimid (lenalidomide) once again requested a review on extended coverage on a maintenance therapy to prevent relapse in patients who had stem cell transplantation, which was not granted. The combined company of Bristol Myers Squibb (BMS) and Celgene offered a financial impact solution plan for the coverage on the maintenance therapy indication, but the committee did not change its mind. However, the committee green-lit the reimbursement on Pomalyst (pomalidomide) as a second-line therapy, extended from the current coverage on third-line therapy. Specifically, the approval was granted on the Pomalyst, Velcade (bortezomib) and dexamethasone combination therapy in patients with multiple myeloma, who have previously received one or more treatment including Revlimid. With the latest approvals, BMS and Celgene combined have received approval on two out of three items in the first Cancer Committee meeting held since their merge.
- Company
- General Hospitals to prescribe AbbVie Skyrizi with coverage
- by Eo, Yun-Ho Jun 05, 2020 06:10am
- General hospitals are ready to prescribe now listed Skyrizi, the fourth interleukin inhibitor in the Korean market. Pharmaceutical industry sources reported drug committees (DC) at Korea University Ansan Hospital, Soonchunhyang University Bucheon Hospital, Design Hospital, Gangnam Severance Hospital, Dankook University Hospital, Hallym University Kangnam Sacred Heart Hospital and Korea University Guro Hospital have cleared interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab) for the treatment of patients with severe psoriasis. Skyrizi has been listed for National Health Insurance (NHI) reimbursement from June 1. The coverage would be granted to patients with chronic psoriasis at a severe level expressed for over six months, who show symptoms of plague psoriasis on 10 percent and more of their body surface area, score 10 or higher on Psoriasis Area and Severity Index (PASI) and demonstrate no reaction to three months of or longer administration of methotrexate (MTX) or cyclosporine or cannot maintain the therapy due to adverse reaction, or demonstrate no reaction despite receiving UVB phototherapy for over three months or cannot maintain the therapy due to adverse reaction. From now on, Korea’s interleukin inhibitor drug market would be divided among four competitors including Novartis’ IL-17A inhibitor Cosentyx (secukinumab), Lilly’s IL-17 inhibitor Taltz (ixekizumab) and Janssen’s IL-23 inhibitor Tremfya (guselkumab), as well as Skyrizi. All four drugs have been first approved as a psoriasis treatment, but they are respectively expanding their indications in autoimmune disease sector. Professor Youn Sang Woong of Department of Dermatology at Seoul National University Bundang Hospital said, “Skyrizi has outstanding benefit in skin condition improvement, safety and convenience, which would greatly help patients to achieve their most wanted goal of maintaining clean skin for a long time.” Skyrizi has confirmed efficacy and safety in treatment through four clinical trials including UltIMMa-1, UltIMMa-2, IMMvent and IMMhance studies. The UltIMMa-1 and UltIMMa-2 studies found 75 percent of patients using Skyrizi have reached 90 percent skin improvement (PASI 90) at week 16, and 36 percent and 51 percent of patient groups in respective studies have shown 100 percent skin improvement (PASI 100). Analyzing the patients who received Skyrizi during the two trials, the treatment effect in most of the patients who demonstrated PASI 90 and PASI 100 has been maintained even after a year.
- Policy
- Remdesivir's special import was decided
- by Lee, Tak-Sun Jun 05, 2020 06:10am
- RemdesivirThe special import of Gilead’s Remdesivir was decided. It will be used in severely hospitalized patients infected with the COVID-19. The MFDS (Minister Lee Eui-kyung) decided to import special cases for Remdesivir, which is being developed as a treatment for COVID-19, and accordingly, the KCDC (Director Eun-Kyung Jung), announced on the 3rd that it is planning to negotiate with the MFDS and Gilead science Korea as soon as possible In the special drug import system, the MFDS imports unlicensed drugs from the country through importers at the request of the relevant ministries in order to deal with the public health crisis, such as pandemic of infectious diseases. The KCDC requested the special import from the MFDS, as the 'Clinical Committee for Infectious Diseases' proposed the introduction of 'Remdesivir' as a treatment for COVID-19 in Korea. As a result, the MFDS announced that it had decided to import special cases after deliberation by the National Stabilization and Supply Council for Essential Drugs (Disease Management Subcommittee). The MFDS judged that the shortening of the treatment period in severe patients due to the use of Remdesivir was clinically meaningful and that it was necessary to secure additional therapeutic agents. In addition, the US, Japan, and the United Kingdom are also considering the fact that the use of Remdesivir in the COVID-19 Pandemic situation was also considered. The government announced that it will support as much as possible to ensure that the medicines are imported as soon as possible, along with domestic importer Gilead Sciences Korea. Remdesivir is used for COVID-19 confirmed patients through PCR tests, in case of ▲Patients who have 94% or less of oxygen saturation (SpO2) in room air ▲Patients who need supplemental oxygen treatment ▲Non-invasive or invasive machines. It is used for severely hospitalized patients, such as those requiring ventilation or extracorporeal membrane oxygen therapy (ECMO). The total administration period is within 10 days.
